The following data is part of a premarket notification filed by Universal Bodycare (i) Sdn. Bhd. with the FDA for Nr Latex Examination Gloves.
| Device ID | K891010 |
| 510k Number | K891010 |
| Device Name: | NR LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | UNIVERSAL BODYCARE (I) SDN. BHD. 102, JALAN IMBI Kuala Lumpur, MY 55100 |
| Contact | Jasvant Singh |
| Correspondent | Jasvant Singh UNIVERSAL BODYCARE (I) SDN. BHD. 102, JALAN IMBI Kuala Lumpur, MY 55100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-07-14 |